HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical evidence.
FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for T...
Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.
FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical device...
Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignation.
A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in gener...
FDA asks manufacturers of generic Accutane to update the drugs labeling.
